Disorders of the stomach are very common and induce a significant amount of morbidity and suffering in the population. Data from hospitals indicate that more than 25% of the population suffers from some type of chronic stomach disorder including abdominal pain and indigestion. Many and various diseases can cause impairment of gastric function; the growing list ranges from functional changes after surgery to inherited disorders, neurologic diseases, connective tissue disorders, metabolic abnormalities, mental stress and infections. Premature infants and/or low birth weight infants have an immature gastrointestinal tract that can be associated with delayed gastric emptying.
Delayed gastric emptying is involved in many of the gastric diseases as a cause or as a result. Delayed gastric emptying may lead to negative nutritional and metabolic consequences. The impact of the often limited ability of patients to tolerate oral intake negatively affect the overall caloric intake, leading to deficiency and lack in essential nutrients.
Delayed gastric emptying affects tens of millions of patients who are diagnosed with various functional gastrointestinal disorders, including gastroesophageal reflux disease (GERD), non-ulcer dyspepsia (NUD) and gastroparesis (including diabetic gastroparesis, which affects half of all diabetes patients).
Many factors may cause delayed gastric emptying, not all of them are known. For example, the peptide hormone Cholecystokinin (CCK), which has most effect on gall bladder contractions, also decreases gastric emptying by contracting the Pylorus. The Pylorus is the lower section of the stomach that facilitates emptying the contents into the small intestine. Another example is the finding that patients with chronic Helicobacter pylori infection are likely to suffer from impaired gastric emptying.
GERD is typically caused by changes in the barrier between the stomach and the esophagus, causing expulsion of gastric reflux. It was shown to be associated with delayed gastric emptying in approximately 40% of the patients (Bais et al., Ann Surg. August 2001; 234(2): 139-146).
NUD is a general name for dyspepsia diseases that their cause is not known. Examples for known dyspepsia diseases are duodenal ulcer, stomach ulcer, oesophagitis (inflamed oesophagus), gastritis (inflamed stomach), etc. Delayed gastric emptying has been considered to play a role in NUD (Miyaji et al., Aliment Pharmacol Ther 1999; 13: 1303-1309).
Gastroparesis affects millions of individuals worldwide and most patients face a delay in diagnosis. In gastroparesis, the stomach motility is reduced and food remains stagnant in the stomach. The most common cause of gastroparesis is diabetes but it can also occur from a blockage at the distal end of stomach, a cancer or a stroke. Symptoms of gastroparesis includes abdominal pain, fullness, bloating, nausea, vomiting after eating food, loss of appetite and feeling of fullness after eating small amounts of food.
Gastroparesis is defined by the presence of dyspeptic symptoms and the documented delay in gastric emptying of ingested nutrients in the absence of gastric outlet obstruction (Klaus Bielefeldt, scientifca, Volume 2012, Article ID 424802, 19 pages).
Various methods are used for diagnosing delayed gastric emptying. For example, U.S. Pat. No. 6,548,043 discloses methods for measurement of gastric emptying. The method includes a test meal with 13C tracer which is administered to a patient followed by measuring the breath sample for 13CO2. The amount of 13CO2 over time determines the gastric emptying activity. In neonates, aspiration of gastric residuals and measurement of the aspirated volume can be an indicator of gastric emptying.
There is a recognized need for additional therapeutic means and compositions for treating gastric disorders, particularly delayed gastric emptying disorders.